Efficacy and Safety of HRS9531 Tablet in Obese Subjects

NCT ID: NCT06841445

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2025-12-31

Brief Summary

To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.

Conditions

Chronic Management of Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group A: HRS9531 Tablet

Group Type: EXPERIMENTAL

HRS9531 Tablet

Intervention Type: DRUG

HRS9531 Tablet dose 1

Treatment group B: HRS9531 Tablet

Group Type: EXPERIMENTAL

HRS9531 Tablet

Intervention Type: DRUG

HRS9531 Tablet dose 2

Treatment group C: HRS9531 Tablet

Group Type: EXPERIMENTAL

HRS9531 Tablet

Intervention Type: DRUG

HRS9531 Tablet dose 3

Treatment group D: HRS9531 Tablet Placebo

Group Type: PLACEBO_COMPARATOR

HRS9531 Tablet placebo

Intervention Type: DRUG

HRS9531 Tablet placebo

Interventions

HRS9531 Tablet

HRS9531 Tablet dose 1

Intervention Type: DRUG

HRS9531 Tablet

HRS9531 Tablet dose 2

Intervention Type: DRUG

HRS9531 Tablet

HRS9531 Tablet dose 3

Intervention Type: DRUG

HRS9531 Tablet placebo

HRS9531 Tablet placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Able and willing to provide a written informed consent;

2. Male or female subjects, 18-65 years of age at the time of signing informed consent;

3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;

4. Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;

5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

Exclusion Criteria

1. Uncontrollable hypertension;

2. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;

3. PHQ-9 score ≥15;

4. Medical history or illness that affects body weight;

5. History of diabetes;

6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;

7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;

8. Any organ-system malignancies developed within 5 years;

9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;

10. History of alcohol and/or substance abuse or drug abuse;

11. Use of any medication or treatment that may have caused significant weight change within 3 months;

12. History of bariatric surgery;

13. Known or suspected hypersensitivity to trial product(s) or related products;

14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

15. Surgery is planned during the trial;

16. Mentally incapacitated or speech-impaired;

17. Acute or chronic hepatitis;

18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

HRS9531-T-201

Identifier Type: -

Identifier Source: org_study_id